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Personalized Therapy in Non-small Cell Lung Cancer (PTINCLC)
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Purpose
Excision repair cross complementing 1 (ERCC1) ribonucleotide reductase M1 (RRM1) and thymidylate synthase(TS) are molecular determinants that predict sensitivity or resistance to platinum agents 、 gemcitabine and pemetrexed respectively.
Tailored therapy using these molecular determinants suggested patient benefit in a previously reported phase 2 trial. Here, we designed a study for an individual patient analysis of prospectively accrued patients who were treated with the "personalized therapy" approach versus other standard approaches.
| Condition | Intervention | Phase |
|---|---|---|
| Lung Cancer Carboplatin Adverse Reaction | Drug: carboplatin, gemcitabine , pametrexed | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | The Clinical Study of Personalized Therapy for Non-small Cell Lung Cancer Based on ERCC1/RRM1/TS Expression |
- The disease-free survival [ Time Frame: Followed up these patients for disease-free survival for 4 years ]The disease-free survival was measured from the day of tumor resection until tumor recurrence (progression) or death as the end point
| Enrollment: | 128 |
| Study Start Date: | June 2009 |
| Study Completion Date: | December 2014 |
| Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A.individual therapy
Carboplatin was administrated at an area under the plasma concentration time curve (AUC) of 5 on day 1 every 21 days, while gemcitabine was administrated at a dose of 1250 mg/m2 on day 1 and 8 and pemetrexed was administrated at a dose of 500 mg/m2 on day 1.
|
Drug: carboplatin, gemcitabine , pametrexed
A.individual therapy :enrolled patients with ERCC1 negative tumors who received carboplatin and a third-generation agent (gemcitabine or pametrexed) based on RRM1 or TS expression. If RRM1 protein was negatively expressed in the tumor tissues, gemcitabine was used, whereas pemetrexed was used if RRM1 was positively expressed and TS was negatively expressed. B.non-individualized therapy :enrolled patients who received carboplatin and a third-generation agent but were not based on ERCC1, RRM1, or TS expression. |
|
Experimental: B. non-individualized therapy
Carboplatin was administrated at an area under the plasma concentration time curve (AUC) of 5 on day 1 every 21 days, while gemcitabine was administrated at a dose of 1250 mg/m2 on day 1 and 8 and pemetrexed was administrated at a dose of 500 mg/m2 on day 1.
|
Drug: carboplatin, gemcitabine , pametrexed
A.individual therapy :enrolled patients with ERCC1 negative tumors who received carboplatin and a third-generation agent (gemcitabine or pametrexed) based on RRM1 or TS expression. If RRM1 protein was negatively expressed in the tumor tissues, gemcitabine was used, whereas pemetrexed was used if RRM1 was positively expressed and TS was negatively expressed. B.non-individualized therapy :enrolled patients who received carboplatin and a third-generation agent but were not based on ERCC1, RRM1, or TS expression. |
Detailed Description:
Patients who had nonsmall- cell lung cancer (NSCLC) performance status of 0/1 were accrued to 2 phase 2 clinical trials Trial A (carboplatin and chemotherapy individuation based on sensitivity marker ), Trial B (carboplatin non-individuation or chemotherapy non-individuation ).
Patients who were treated on Trials B were analyzed as the "standard therapy" group. Patients accrued to Trial A were called the "personalized therapy" group. disease free survival (DFS) was estimated using the Kaplan-Meier method.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically confirmed non-small cell lung cancer
- age from 18 years to 75 years
- ECOG Performance Status no more than 2
- at least one appraisable lung focus of diameter≥ 10 mm by lung CT
- Haemoglobin ≥10.0 g/dl, Absolute neutrophil count ≥(ANC) 1.5 x 109/L, platelets ≥100 x 109/L
- Total bilirubin ≤1.5 x upper limit of normal (ULN)
- ALT and AST < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases
- Creatinine clearance ≥60ml/min (calculated according to Cockcroft-gault formula)
- Informed consent should be obtained before treatment.
Exclusion Criteria:
- Mixed non-adenocarcinoma cell lung cancer histology
- Previous treatment for Systemic chemotherapy or local radiotherapy
- Be allergic to chemotherapy drugs
- second active primary malignancy or serious concomitant medical disease
- difficulties with adequate follow-up
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01781988
| China, Guangdong | |
| The first affiliated hospital of Guangzhou MC | |
| Guangzhou, Guangdong, China, 510120 | |
| Study Chair: | Jianxing He, Proressor | The first affiliated hospital of Guangzhou MC |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Heyuwen, Yuwen He, MD, Guangzhou Medical University |
| ClinicalTrials.gov Identifier: | NCT01781988 History of Changes |
| Other Study ID Numbers: |
GZMC12521 PT12521 ( Other Identifier: The First Affiliated Hospital of Guangzhou Medical University ) |
| Study First Received: | January 24, 2013 |
| Last Updated: | December 15, 2014 |
Keywords provided by Heyuwen, Guangzhou Medical University:
|
lung cancer gemcitabine carboplatin pemetrexed |
Additional relevant MeSH terms:
|
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Gemcitabine Pemetrexed Carboplatin |
Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on August 18, 2017